NCT04584255

Niraparib + Dostarlimab In BRCA Mutated Breast Cancer

A Phase II Study of Niraparib With Dostarlimab Therapy as Neoadjuvant Treatment for Patients With BRCA-mutated Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study involves pre-operative therapy that is specifically targeted for breast cancer in individuals with BRCA and PALB2 mutations. The names of the study drugs involved in this study are: * Niraparib (Zejula) * Dostarlimab

Detailed description

The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies, imaging assessments, and follow up visits. Participants will receive treatment for 18 weeks. After 18 weeks, participants will be evaluated to determine if a candidate for surgery or if additional treatment outside of the study. Participants with triple negative breast cancer will be randomized to one of two treatment arms. * Arm A: Niraparib with Dostarlimab for 18 weeks * Arm B: Niraparib alone for 3 weeks, followed by Niraparib with Dostarlimab for 15 weeks Participants with estrogen receptor positive breast cancer will be placed directly into Arm C. There is no randomization for these participants. \- Arm C: Niraparib with dostarlimab for 18 weeks It is expected that about 62 people will take part in this research study. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug or drug combination to learn whether the drug combination works in treating a specific disease. "Investigational" means that the study drugs, Niraparib and Dostarlimab, are being studied for use in this setting and the research doctors are trying to learn more about the drug combination-the side effects the combination may cause and if it is effective in treating this type of cancer. The U.S. Food and Drug Administration (FDA) has not yet approved either of the drugs in this study for your type of cancer. Niraparib has been approved by the FDA for treatment of advanced ovarian cancer in BRCA mutation carriers. The use of Dostarlimab in this research study is experimental, which means that it is not approved by any regulatory auit is not approved by any regulatory authority, including the FDA, for treatment of breast cancer, or any other disease.

Conditions

• Stage I Breast Cancer
• Stage II Breast Cancer
• Stage III Breast Cancer
• Breast Cancer
• HER2-negative Breast Cancer
• Germline BRCA1 Gene Mutation
• Germline BRCA2 Gene Mutation
• Deleterious PALB2 Gene Mutation

Interventions

Type	Name	Description
DRUG	Niraparib	Predetermined dosage PO Daily
DRUG	Dostarlimab	Predetermined Dosage, IV,q3 weeks

Timeline

• Start date: 2020-12-18
• Primary completion: 2025-07-01
• Completion: 2029-07-17
• First posted: 2020-10-12
• Last updated: 2025-07-28

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study